Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

October 14, 2024 updated by: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study

The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are:

  • Is the virtual ileostomy a safe and effective alternative to the ileostomy?
  • Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma.

Participants will:

  • Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer
  • Continuous follow-up of their complications after the first surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a national multicenter, large-sample, randomized controlled study

Study Type

Interventional

Enrollment (Estimated)

620

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China, 400042
        • Recruiting
        • Daping Hospital, Third Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of rectal cancer confirmed by pathology
  • Age ≥ 18 years
  • Total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis：1.anterior resection (AR/ PME), 2. low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)
  • Signed informed consent
  • Ability to understand the nature and risks of participating in the trial

Exclusion Criteria:

  • Emergency surgery, open surgery
  • ASA score >3points
  • Patients with combined complete intestinal obstruction
  • Long-term history of using immunosuppressants or glucocorticoids
  • Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2. Patients with a history of myocardial infarction or coronary artery surgery within 6 months before the procedure
  • Chronic renal failure (requiring dialysis or glomerular filtration rate <30 mL/min)
  • Intraoperative combined multi-organ resection
  • Combined cirrhosis of the liver
  • Intraoperative findings of incomplete anastomosis and positive insufflation test
  • Modified Bacon procedure(Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis)
  • Due to an intraoperative accident the surgeon felt that a diverting ileostomy was necessary.
  • Currently participating in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual ileostomy
A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.
Procedure: Virtual ileostomy
A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.
No Intervention: Diverting ileostomy
Diverting ileostomy (DI) is a common fecal diversion procedure performed in patients undergoing total mesorectal excision (TME) procedure for rectal cancer to protect the anastomosis and reduce the risk of complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication index (CCI) at the 6th postoperative month
Time Frame: An average of 6 month from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications
The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
An average of 6 month from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative
Time Frame: 5 year
The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
5 year
First postoperative complications
Time Frame: From the date of randomization until the date of discharge, an average of 7 to 14 days
First postoperative complications(including abdominal abscess, peritonitis, anastomotic leakage, anastomotic bleeding, pelvic infection, surgical incision infection, peritonitis, anastomotic stenosis, intestinal obstruction, peri-wound complications, incisional hernia, and others) based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
From the date of randomization until the date of discharge, an average of 7 to 14 days
Stoma-related complications
Time Frame: Through study completion, an average of 5 year
Wounds/abscesses/edema/dermatitis/ulcers around the diverting Ileostomy; parastomal hernia; stoma prolapse; acute kidney injury; dehydration/output >1500 mL/day； other stoma-related complications
Through study completion, an average of 5 year
Complications after ileostomy closure
Time Frame: Through study completion, an average of 5 year
Anastomotic leakage； intestinal anastomotic leakage； anastomotic stenosis; bowel obstruction; other wound complications （Wound dehiscence/bleeding/sinus tract/abscess/fat liquefaction）; burst abdomen (dehiscence of abdominal fascia); incisional hernia; fecal incontinence; reoperation; other complications
Through study completion, an average of 5 year
Postoperative hospitalization days(Initial and all subsequent hospitalizations)
Time Frame: Through study completion, an average of 5 year
Patients in the virtual stoma group who did not have a second surgery due to complications recorded days of postoperative hospitalization after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record days of postoperative hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Through study completion, an average of 5 year
The number of hospitalizations(Initial and all subsequent hospitalizations)
Time Frame: Through study completion, an average of 5 year
Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalizations after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Through study completion, an average of 5 year
Duration of bearing the stoma (months)
Time Frame: Through study completion, an average of 5 year
If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the duration of bearing the stoma since the data of surgery of diverting ileostomy.
Through study completion, an average of 5 year
Total hospitalization costs(Initial and all subsequent hospitalizations)
Time Frame: Through study completion, an average of 5 year
Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs after the first surgery for rectal cancer, if the virtual stoma group required bedside or secondary surgery for converted to diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the costs due to complications and reoperation since the data of the first surgery for rectal cancer.
Through study completion, an average of 5 year
Number of participants with terminal ostomy
Time Frame: Through study completion, an average of 5 year
Hartmann's procedure or for example, abdominoperineal extirpation，and transverse colostomy
Through study completion, an average of 5 year
Number of Participants with unscheduled secondary surgery
Time Frame: Through study completion, an average of 5 year
Patients performed unscheduled secondary surgery due to complications.
Through study completion, an average of 5 year
The rate at which virtual ileostomy was converted to diverting ileostomy
Time Frame: Through study completion, an average of 5 year
The virtual ileostomy group required bedside or secondary surgery to convert to diverting ileostomy due to complications
Through study completion, an average of 5 year
Virtual ileostomy remove time(days)
Time Frame: During hospitalization,approximately 14 days
Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.
During hospitalization,approximately 14 days
Bile acid concentration of drainage fluid
Time Frame: During hospitalization,approximately 7 days
The investigators are monitoring the concentration of bile acids in the first postoperative drainage fluid.
During hospitalization,approximately 7 days
Number of participants with stoma (terminal/loop) at 6 months after initial surgery
Time Frame: 6 months from the date of first surgery for rectal cancer
Patients carrying stoma 6 months after the first surgery for rectal cancer
6 months from the date of first surgery for rectal cancer
Interventional drainage rate
Time Frame: Through study completion, an average of 5 year
Patient requires interventional drainage due to complications.
Through study completion, an average of 5 year
Fecal Incontinence Scale(Wexner Score)
Time Frame: Through study completion, an average of 5 year
The defecation function of all postoperative patients. Wexner score range is 0-20 points, with 0 points indicating normal and 20 points indicating complete incontinence.
Through study completion, an average of 5 year
Quality of life(EORTC QLQ-C30)
Time Frame: Through study completion, an average of 5 year
The quality of life of all patients was assessed using relevant scales[EORTC (The European Organization for Reasearch and Treatment of Cancer) QLQ-C30(Quality of Life Questionnare-Core 30)]. The EORTC QLQ-C30 (V3. O) consists of 30 entries, which can be divided into 15 domains, including 5 functional domains (physical, role, cognitive, emotional, and social functions), 3 symptom domains (fatigue, pain, nausea, and vomiting), 1 overall health/quality of life domain, and 6 individual entries (each as a domain). EORTC QLQ-C30 has a total of 30 entries. Among them, entries 29 and 30 are divided into seven levels, ranging from 1 to 7 points based on their answer options; the other entries are divided into 4 levels: none(1 point), a little（2 points）, more（3 points）, many（4 points）. The QLQ-C30 scale is reversed except for items 29 and 30 (the higher the value, the worse the quality of life).
Through study completion, an average of 5 year
Disease free survival (DFS)
Time Frame: Through study completion, an average of 5 year
Disease free survival
Through study completion, an average of 5 year
Overall survival (OS)
Time Frame: Through study completion, an average of 5 year
Overall survival
Through study completion, an average of 5 year
Rate of permanent ileostomy
Time Frame: From the date of first surgery,an average of 3 year
Patients who underwent diverting Ileostomy were converted to permanent ileostomy.
From the date of first surgery,an average of 3 year
Completion of intended perioperative or adjuvant chemotherapy
Time Frame: Through study completion, an average of 5 year
Completion of intended perioperative or adjuvant chemotherapy
Through study completion, an average of 5 year
Low anterior resection syndrome for rectal cancer
Time Frame: Through study completion, an average of 5 year
The investigators use LARS scale to evaluate the patient's defecation function.The LARS rating scale consists of 5 questions: voiding incontinence, fluid voiding incontinence, frequency of voiding, voiding aggregation, and voiding urgency. 0-20 is classified as no LARS, 21-29 is classified as mild LARS, 30-42 is classified as severe LARS.
Through study completion, an average of 5 year
Quality of life for fecal incontinence
Time Frame: Through study completion, an average of 5 year
The Fecal Incontinence Quality of Life Scale (FIQL) is mainly used to evaluate the quality of life of patients with fecal incontinence. It includes four main aspects: lifestyle changes, psychological coping/behavioral limitations, depression/self-perception, and social embarrassment. The FIQL is analyzed as a total score; the higher the patient's score, the higher the patient's quality of life.
Through study completion, an average of 5 year
Permanent ileostomy rate
Time Frame: 3 years from the date of first surgery for rectal cancer
Patients with diverting ileostomy who underwent sphincter-saving surgery for rectal cancer were converted to permanent ileostomy.
3 years from the date of first surgery for rectal cancer
Mortality
Time Frame: 30 days from the date of first surgery for rectal cancer
30-day mortality
30 days from the date of first surgery for rectal cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

  • Study Chair: fan li, Daping Hospital, Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIRTUAL 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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